Job Description Summary: The Director, Clinical Development provides tactical oversight for the clinical/medical aspects of all phases of the clinical drug development process.
The incumbent is involved in the design, development and execution of Clinical Development Plans (CDPs), clinical trials and protocols in accordance with applicable Good Clinical Practice (GCP) regulations. The incumbent leads and contributes to the analysis of study results, the assessment of the extent to which the study(ies) has achieved clinical, regulatory and commercial objectives and the documentation of study results.
As needed, he/she may be assigned as the primary clinical/medical representative in meetings with external stakeholders, partners or other external audiences as needed. This includes, but may not be limited to, Key Opinion Leaders (KOLs), investigators, regulatory authorities, partners, vendors, consultants, etc. As such he/she may author or review clinical/medical-related materials intended for external audiences.
The incumbent works cross-functionally with internal departments and external resources on Clinical Development related issues.
The Director, Clinical Development ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Job Description:ESSENTIAL FUNCTIONSPrimary duties/responsibilities:
- Contributes to, reviews and approves study protocols, protocol amendments, study manuals, Investigator Brochures (IBs), Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs) and other clinical documents as required for the conduct of clinical trials.
- Approves investigator sites for inclusion in study/studies. Plans and facilitates investigator meetings and presents selected sections of the agenda/content.
- Prepares weekly and/or monthly study update reports which contain detailed information on enrollment data and adverse events as well as other general information relating to the progress of the study.
- Interprets, summarizes and documents clinical data for CSRs, regulatory documents (e.g. INDs, Annual Reports, NDAs, MAAs, etc.) manuscripts, promotional material and other publications as required.
- Approves and monitors clinical study timelines.
- Contributes to vendor selection process and manages PTC's relationship with certain external vendors, partners and investigators.
- May represent the clinical study team at cross-functional, integrated team meetings.
- Ensures adherence to appropriate regulations and SOPs.
- Participates in the clinical review and recommendation of new opportunities such as target selections or clinical due diligence.
- Provides clinical/medical input to non-clinical and commercial functions.
- Performs other tasks and assignments as needed and specified by management.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED* Minimum level of education and years of relevant work experience.
- MD degree and a minimum of 2 years of clinical drug development experience within a pharmaceutical, biotechnology or related environment.
* Special knowledge or skills needed and/or licenses or certificates required.
- Demonstrated experience managing one or more global, clinical programs.
- Knowledge of the pharmaceutical/biotechnology industry, including global drug development and regulatory processes, with particular knowledge of R&D, key clinical milestones, and the factors influencing critical development and decision-making points.
- Demonstrated expertise in clinical trial design, conduct and interpretation of clinical data.
- Previous experience with regulatory submissions.
- Ability to influence without direct authority.
- Proficiency with Microsoft Office.
- Excellent verbal and written communication and skills.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Ability to travel domestically and internationally.
*Special knowledge or skills and/or licenses or certificates preferred.
- Board certification or equivalent in a medical/clinical specialty
- Experience working in rare/orphan disease clinical development.
* Travel requirements
Expected Base Salary Range: $2866,900 - $336,000. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.
In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans.
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